A sterility test for cell therapy products returns yes/no results within 30 minutes for a range of microbial contaminants. Such detection speed is the result of combining machine learning (ML) and ...
The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
It's an exciting time to be in cell therapy manufacturing and commercialization, particularly in the oncology space. This year alone, we've seen the US approval of three cell therapy products: Iovance ...
Controlling the entire cell therapy production process—from material receipt to product release—is “essential,” according to AstraZeneca, which says its new $300 million manufacturing facility will be ...
This review article highlights the transformative potential of in vivo CAR T cell therapy in addressing the limitations of traditional CAR T cell production. This innovative approach could ...
While many articles have been written about cell testing in R&D labs or cell testing during manufacturing in the factory, let’s turn to the topic of cell testing for incoming inspection. This article ...
The outlook for stem-cell therapies in Florida has grown, driven by a 2025 law that widens the path for doctors to use stem ...
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